AccessGUDID - DEVICE: Cor-Valv Atrial Retractor Cables with Fitting (00817121000198)

GUDID

Device Identifier (DI) Information

Brand Name: Cor-Valv Atrial Retractor Cables with Fitting
Version or Model: 1011180
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1011180
Company Name: Coroneo Inc

Primary DI Number: 00817121000198
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 255276362 *Terms of Use

Device Description: The Cor-Valv Cable is intended to be used with the corresponding CORONEO Cor-Valv system retractor for retraction of heart tissue during cardiac surgery. This product is provided sterile in a sealed package, and consists one(1) cable that is single-use and disposable held by a plastic insert.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46774	Surgical retractor/retraction system blade, reusable	A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAD	Retractor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 28ece483-476d-4dfb-994a-550ed06bb06c
Public Version Date: March 01, 2023
Public Version Number: 2
DI Record Publish Date: September 28, 2022